Revised: 31 May 2019
Medical Devices
Revised: 25 September 2018
Surgical Mesh – Safety Information
Surgical mesh is a medical device that is used when repairing weakened structures with the aim of providing additional support. It can be absorbable or non-absorbable. Non-absorbable mesh will remain in the body indefinitely so should be considered a permanent implant.
Surgical mesh is in use for urogynaecological surgery including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Surgery is used to treat pelvic organ prolapse when other non-invasive treatments have been found to be not suitable or have failed. The use of mesh in surgery was introduced in response to the high failure rate of both initial surgery and revision surgery estimated at about 30%1, with the aim of augmenting the surgery and reducing the failure rate.
Surgical mesh is also widely used for hernia repair.
Adverse Event Reporting and Monitoring
Information on adverse event reporting including reporting forms and guidance.
Information for Healthcare Professionals
Guidance provided by Medsafe and links to other published clinical and regulatory guidance
Implementation
Implementation of Government Response to Report of the Health Committee on Petition 2011/102
Overseas Actions and Reviews
Information on overseas reviews and actions being taken in that country